Michael Köhler

Contributions

Early benefit assessment of new drugs: The impact on healthcare in Germany - Volume 30, Issue 3

The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…

Why clinical study reports really matter - Volume 27, Issue 2

Clinical study reports (CSRs) have so far served as documents for drug approval, but not as a data source for further use in research and post-regulatory decision-making. Sound post-regulatory decisions also require data other than those available…

Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies - Volume 22, Issue 3

For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…

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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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